Cleared Traditional

HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS (K855150) - FDA 510(k) Clearance

K855150 · Hpk International, Inc. · Gastroenterology & Urology device
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Apr 1986
Decision
96d
Days
-
Risk

K855150 is an FDA 510(k) clearance for the HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Hpk International, Inc. (Washington, US). The FDA issued a Cleared decision on April 1, 1986 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K855150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1985
Decision Date April 01, 1986
Days to Decision 96 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 130d · This submission: 96d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -